C,C'-azodi(formamide)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 15 through April 29, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: It was noted that the study report lacked a number of important details (specifically regarding the test material, such as the expiry date), however the study was conducted in accordance with EC and OECD test guidelines, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

C,C'-azodi(formamide)

EC Number:

204-650-8

EC Name:

C,C'-azodi(formamide)

Cas Number:

123-77-3

Molecular formula:

C2H4N4O2

IUPAC Name:

diazene-1,2-dicarboxamide

Details on test material:

- Name of test material (as cited in study report): Unifoam AZ SO-NL
- Substance type: yellow powder
- Physical state: solid
- Analytical purity: 100%
- Impurities (identity and concentrations): none reported
- Lot/batch No.: Not reported.
- Expiration date of the lot/batch: Not reported.
- Stability under test conditions: Not reported.
- Storage condition of test material: Ambient temperature, in the dark.

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River U.K. Limted, Margate, Kent, England
- Age at study initiation: four to six weeks
- Weight at study initiation: 113 to 146 gram
- Fasting period before study: overnight prior to thru 4 hours after dosing
- Housing: in groups, by sex, in metal cages with wire mesh floors
- Diet (e.g. ad libitum): standard rodent diet (Labsure LAD1) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: nine days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23 °C
- Humidity (%): 57%
- Air changes (per hr): 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: methylcellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25% w/v concentration

MAXIMUM DOSE VOLUME APPLIED: 20.0 ml/kg

Doses:

5 g/kg

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 Days
- Frequency of observations and weighing:Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of five hours). On subsequent days the animals were observed once in the morning and again at the end of the experimental day. This latter observation was at approximately 16.30 hours on week days or 11.30 hours on Saturday and Sunday. Clinical signs were recorded at each observation.
- Necropsy of survivors performed: yes
- Other examinations performed: All animals on the main study were killed on Day 15 by cervical dislocation and were subjected to a macroscopic post mortem examination which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of abnormal organs when present was recorded.

Results and discussion

Preliminary study:

Results of the preliminary study indicated that the acute lethal oral dose of Unifoam AZ SO-NL was greater that 5.0 g/kg bodyweight. One group of ten rats (five males and five females) was dosed at 5.0 g/kg to confirm the result of the preliminary study.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

no mortality

Clinical signs:

other: Pilo-erection and abnormal body carriage (hunched posture) were observed in all rats within five minutes of dosing. Pilo-erection alone persisted throughout the remainder of Day 1. There were no other clinical signs and recovery, as judged by external a

Gross pathology:

Terminal autopsy findings were normal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute lethal oral dose to rats of Unifoam AZ SO-NL was found to be greater than 5.0 g/kg bodyweight.

Executive summary:

An acute oral toxicity test was performed to determine the acute toxicity by oral exposure of the test substance AZ SO-NL. The study was conducted in accordance with relevant EC and OECD test guidelines, and in compliance with GLP (HLS 1988, 88720D/OCI 64/AC).

A group of ten rats (five male and five female) were dosed with 5000 mg test substance/kg bodyweight by oral gavage, then observation for mortality and clinical signs performed over a period of 14 days. At the end of the observation period, all animals were sacrificed and postmortem examinations performed.

No deaths occured in the test rats. Piloerection and hunched posture were seen in all rats within five minutes of dosing, and piloerection persisted for the remainder of the day of dosing; all animals had recovered by day 2 and no further unusual clinical signs were seen. Slightly low bodyweight gains were recorded for two male and one female rat, however all other rats made the anticipated weight gains. Terminal autopsy findings were normal.

The acute lethal oral dose to rats of Unifoam AZ SO-NL was found to be greater than 5.0 g/kg bodyweight.